BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3050009 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03851
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2012
    Report Date
    February 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DISPLAYED DEFIBRILLATOR (ICD) INCREASED PACING THRESHOLD MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED. AFTER REPOSITIONING THE LEAD, THE SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS. WHEN REMOVING THE PROXIMAL COIL FROM THE CONFIGURATION, THE SHOCK IMPEDANCE MEASUREMENTS WERE 70 OHMS. A 21 JOULE SHOCK WAS DELIVERED AND CONVERTED THE PATIENT WITH SHOCK IMPEDANCE MEASUREMENTS OF APPROXIMATELY 56 OHMS. THE PHYSICIAN DECIDED TO LEAVE THE LEAD AS THE DEFIBRILLATION THRESHOLD TESTING WAS SUCCESSFUL. THE DEVICE REMAINS IN SERVICE WITH NO FURTHER ISSUES REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152968 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR E142| 0296| 4470